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© 2023 MJH Life Sciences and Pharmaceutical Technology. All rights reserved.
© 2023 MJH Life Sciences™ and Pharmaceutical Technology. All rights reserved.
January 02, 2023
In light of increasingly stringent sustainability requirements, bio/pharma companies need to make sure they formulate effective ESG strategies.
A CCS provides significant benefits to the industry and helps with holistically understanding contamination controls, says Siegfried Schmitt, vice president, Technical at Parexel.
December 20, 2022
This article focuses on drawing parallels between ICH Q14/Q2(R2), United States Pharmacopeia (USP) , and International Organization for Standardization/International Electrotechnical Commission (ISO/IEC) 17025:2017.
December 08, 2022
FDA struggles to track shortages caused by a rise in demand.
The most safe and effective therapies demand the highest data quality.
December 03, 2022
QMM is an evolutionary advancement in FDA’s quality management maturity initiative that provides industry with a viable methodology to assess and improve manufacturing quality and supply chain reliability.
December 02, 2022
Susan J. Schniepp, distinguished fellow for Regulatory Compliance Associates, provides simple answers to frequently asked questions regarding batch records.
November 21, 2022
Element has opened a new 7500-ft3 facility that will be used to evaluate aerosolized product efficacy for reducing airborne organisms and viral particles.
November 03, 2022
Data analytics, modular equipment, digital tools, and risk-based validation improve speed, flexibility, and quality.
November 02, 2022
Industry experts discuss best practices for certificates of analysis.